Transoral Robotic Surgery or Standard Surgery in Treating Patients With Benign or Malignant Tumors of the Larynx and Pharynx

Head and Neck Cancer Clinical Trial

Official title:

A Pilot Study Assessing the Use of DA VINCI® Robotic Surgical System in Laryngeal and Pharyngeal Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918762
• Other study ID #: CDR0000642940
• Secondary ID: P30CA022453WSU-2
• Status: Completed
• Phase: Phase 1
• First received: June 9, 2009
• Last updated: May 7, 2014
• Start date: May 2009
• Est. completion date: October 2010

Study information

• Verified date: May 2014
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Transoral robotic surgery may make it easier to find and remove benign or malignant tumors of the larynx and pharynx and cause less damage to normal tissue. It is not yet known whether transoral robotic surgery is more effective than standard surgery in diagnosing and treating larynx and pharynx tumors.

PURPOSE: This phase I trial is studying how well transoral robotic surgery works compared with standard surgery in treating patients with benign or malignant tumors of the larynx or pharynx.

Description:

OBJECTIVES:

Primary

• Evaluate the potential benefits of using the transoral robotic surgical approach against the conventional open and transoral approaches in patients with benign or malignant disease involving the larynx and pharynx.

Secondary

• Determine the proportion of laryngeal and pharyngeal surgical procedures where the surgical exposure is adequate to allow the successful completion of the surgical resection using the transoral robotic surgical approach.

OUTLINE: Patients are assigned to transoral robotic surgery or standard therapy consisting of conventional transoral endoscopic or open approach according to their preference.

Patients undergo planned surgical procedures (either diagnostic or therapeutic) appropriate for their disease in the larynx or pharynx via the transoral robotic surgical approach or the conventional transoral endoscopic or open approach.

Patients complete the Functional Assessment of Cancer Therapy Head and Neck Scale, the Performance Status Scale for Head and Neck Cancer Patients, and the University of Washington Quality of Life Scale at baseline and at 3 and 6 months. Patients also undergo voice analysis by acoustic analyses, and speech and swallow pathology evaluation by videostroboscopy and modified barium swallow.

After completion of study procedure, patients are followed at 3 and 6 months.

PROJECTED ACCRUAL: A total of 80 patients will be accrued to the control group (standard conventional surgery) and 30 patients will be accrued to the robotic surgery group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Benign or malignant disease of the larynx or pharynx that requires surgical intervention for either diagnostic or therapeutic purposes

• Malignant disease must meet the following criteria:

• Histologically confirmed diagnosis of 1 of the following:

• Glottic cancer (T1, T2, and T3)

• Supraglottic cancer (T1, T2, and T3)

• Hypopharyngeal cancer (T1 and T2)

• Oropharyngeal cancer (T1, T2, and T3)

• Nasopharyngeal cancer (T1 and T2)

• Resectable involved lymph nodes

• No invasion of osseous and/or osseocartilaginous structures including the following:

• Mandibular bone

• Thyroid cartilage

• Hyoid bone

• Cricoid bone

• Vertebral body

• No pharyngeal wall or tongue-based involvement requiring resection of > 50% of the posterior pharyngeal wall or tongue base

• No radiological confirmation of carotid artery involvement

• No fixation of tumor to the prevertebral fascia

• No bilateral arytenoid involvement

• No surgical defect requiring open approach for reconstruction

• No evidence of distant metastasis

PATIENT CHARACTERISTICS:

• Not pregnant

• No unexplained fever and/or untreated active infection

• No medical conditions contraindicating general anesthesia

• No inadequate jaw opening due to prior head and neck surgery, trauma, or radiotherapy

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Perioperative/Postoperative Complications
• Postoperative Complications
• Precancerous Condition
• Precancerous Conditions

Intervention

Procedure:
• assessment of therapy complications

• diagnostic endoscopic surgery

• quality-of-life assessment

• therapeutic conventional surgery

• therapeutic endoscopic surgery

• transoral robotic surgery

• video-assisted surgery

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time that directly affects operative cost		post operative	No
Secondary	Blood loss		During surgery	Yes
Secondary	Intra-operative and post-operative complications		during the operation and post operative	Yes
Secondary	Need for reconstruction		post operative	No
Secondary	Margins status		post operative	No
Secondary	Length of hospital stay		during time as inpatient	No
Secondary	Tracheostomy and PEG dependence		post operative	No
Secondary	Days to oral intake		post operative	No
Secondary	Time to locoregional recurrence		post operative	No
Secondary	Speech intelligibility		post operative	No
Secondary	Quality of life		3 months and 6 month following completion of surgery	No
Secondary	Postoperative pain		post operative	No
Secondary	Proportion of robotic surgical cases where adequate surgical exposure allowed for successful operation completion		post operative	No